Pharvaris Announces Orphan Designation Granted to Deucrictibant by the European Commission

Core Insights - Pharvaris has received orphan designation from the European Commission for its investigational drug, deucrictibant, aimed at treating bradykinin-mediated angioedema [1][3] - The U.S. FDA had previously granted orphan drug designation to deucrictibant in March 2022 [2] - The company is currently executing a Phase 3 development program to evaluate the efficacy and safety of deucrictibant in hereditary angioedema (HAE) [3][5] Company Overview - Pharvaris is a late-stage biopharmaceutical company focused on developing oral bradykinin B2 receptor antagonists to address bradykinin-mediated diseases [1][5] - The company aims to provide injectable-like efficacy with the convenience of oral therapy for preventing and treating angioedema attacks [5] - Deucrictibant is being developed in two formulations: an extended-release tablet for sustained absorption and an immediate-release capsule for rapid onset of action [4] Clinical Development - Pharvaris is conducting pivotal Phase 3 studies for both the prevention of HAE attacks (CHAPTER-3) and the on-demand treatment of HAE attacks (RAPIDe-3) [5] - The company is also in discussions with regulators regarding a pivotal trial for acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH) [3]